MERLIN-TIMI 36 is a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of ranolazine during acute and long-term treatment in approximately 5,500 patients with non-ST elevation acute coronary syndromes (ACS) treated with standard therapy. The primary efficacy endpoint in MERLIN-TIMI 36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy. The study also evaluates the safety of long-term treatment with ranolazine compared to placebo.

Time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia through the end of the follow-up in non-ST elevation ACS. [ Time Frame: First occurrence ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Composite of cardiovascular death, myocardial infarction, or severe recurrent ischemia. Safety of long-term treatment with ranolazine compared to placebo; safety endpoints are death from any cause and symptomatic documented arrhythmia. [ Time Frame: First occurence ] [ Designated as safety issue: No ]

Successful revascularization during the qualifying hospitalization, prior to study entry

Acute pulmonary edema, hypotension, or evidence of cardiogenic shock

Clinically significant liver disease

End stage kidney disease requiring dialysis

Concomitant use of drugs known to prolong the QT interval, or any digitalis drugs

Use at study entry of drugs that are strong inhibitors of cytochrome P450 3A4

Pregnant or lactating women, or women of child bearing potential not using an acceptable form of birth control

Additional study entry criteria will be evaluated during initial screening.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00099788